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These highlights do not include all the information needed to use HYDROMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for HYDROMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS. HYDROMORPHONE HYDROCHLORIDE extended-release tablets, for oral use, CIIInitial U.S. Approval: 1984
Medication labelWhy this: Advisory · dailymed-prescription
Hydromorphone hydrochloride extended-release tablets are indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Patients considered opioid tolerant are those who are receiving, for one week or longer, at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid. Limitations of Use Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy, [see Warnings and Precautions (5.1)], reserve opioid analgesics, including hydromorphone hydrochloride extended-release tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Hydromorphone hydrochloride extended-release tablets are not indicated as an as-needed (prn) analgesic.
- generic_name
- hydromorphone hydrochloride
- product_names
- hydromorphone hydrochloride
- ndc
- 31722-119, 31722-120, 31722-121, 31722-122, 31722-119-01, 31722-120-01, 31722-121-01, 31722-122-01
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en